Transcript NISCHR AHSC Presentations

www.cymru.gov.uk
A successful collaboration between
Huntleigh and Cardiff NHS Podiatry Department
Dr Jane Lewis,
Clinical Specialist and Research Podiatrist
 The Diagnostic Products Division of Huntleigh has over 25 years
experience in design, development, manufacturing and marketing
non-invasive electro-diagnostic products to the global medical
market
 Award winning innovators in medical technology
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1982, 1987, 1992 Queen’s Award for Export (Medical Systems)
1993 Queen’s Award for Technological Achievement (Doppler range)
2003 Queen’s Award for Innovation (Vascular Assist range)
2009 MediWales NHS Partnership with Academia and Industry Award
(Ability)
– 2010 IET Innovation Award – Highly Commended (Ability)
 Long standing relationship working with the NHS
 Globally established training programmes in Peripheral Arterial
Disease
Peripheral Arterial Disease
 In Europe and North America an estimated 27 million people have
Peripheral Arterial Disease (PAD) and in the UK around 100,000
people are diagnosed every year.
 PAD patients 6x more likely to die from Coronary Heart Disease
(CHD)
(Belch et al, 2007, Br J Diabetes Vasc Dis 7(5): 236-239)
 In 2012, estimated that 17% of pop (102m) will be > 65 and at
high risk of leg/foot ulcers
 Approximately 20% of population > 65 are asymptomatic PAD
 Inadequate primary care vascular assessments
 Up to 33% inappropriate referrals to Vascular Team (back pain,
neurological pain, nerve entrapment)
Detection of PAD is paramount
and potentially treatable
 Large body of evidence supporting the efficacy of Ankle Brachial
Index (ABI) as an effective diagnostic and risk assessment tool
(Newman, 1999: Papamicheal, 2000: Sikkink, 1997: Zheng, 1997)
 To date, ABI is the most effective, accurate and practical
method of PAD detection (Belch et al, 2003)
 ABI < 0.9 is 95% sensitive in detecting angiogram positive disease
and almost 100% specific in excluding healthy individuals
 ABI < 0.9 is highly predictive of morbidity and mortality from
cardiovascular events linked with PAD (Belch et al, 2003)
 ABI also provides information regarding severity of PAD that can
assist in guiding a treatment approach
Early Collaboration
 In 2002, Huntleigh had previously supported Jane Lewis in her PhD
research, funded by the WAG.
 This work used the Vascular Assist for detecting PAD in diabetic
patients using ABI, toe pressures and Pulse Volume Recordings
(PVR).
 It concluded that:
 advancements in ABI measurements are needed
 PVR had clinical value in assessing diabetic patients with
calcified arteries.
Vascular
Assist
Aim of the New Development
 In 2008, Huntleigh decided to develop a device that would
quickly and easily measure the ABI, not based on the Doppler
technique.
 The new device should:
 be automatic and easy to use
 portable
 require minimal training
 be clinically reliable
 have quantifiable results
 eliminate the need to rest the patient
 allow early identification of PAD and intervention
Two Chamber Cuffs
An innovative two chamber cuff was designed to detect systolic
pressures based on PVR technology
Coinventors
Dr Jon
Evans
Dr Nigel
Gough
The Ability Prototype Unit
 Developed a laptop based
prototype
 Birth of
Automatic Ankle Brachial Index
System
 Tried on volunteers
 Needed to be clinically tested
 Cuff design improvements
 Consulted Cardiff Podiatry
Department
Clinical Performance
Study
Purpose of the study
To evaluate the efficacy of the Ability unit for its agreement and
time taken to conduct the test when compared with the current
gold standard Doppler method for obtaining ABIs
Clinical involvement essential
 Regular brainstorming meetings
 Is study design practical/achievable?
 Is patient target group realistic?
 How easy will it be to recruit patients?
 Is inclusion/exclusion criteria too
tight?
 Measurable study outcomes were
agreed.
Clinical Performance
Study
 Utilised existing Podiatry vascular assessment clinics
 Few patients attending were found to be unsuitable for
study
Sequence
A
10 mins
rest
Ability
rested
(timed)
5 mins
rest
Doppler
rested
(timed)
10 mins
rest
Doppler
rested
(timed)
5 mins
rest
Ability
rested
(timed)
Ability unrested
(timed)
Sequence
B
Doppler in Use
Vascular
Assist
Ability data collection device –
clinician blinded to the data
collected
Results
Agreement of Unrested Ability and Rested Doppler
Bias = –0.064
95% limit of agreement = ±0.22
Objective achieved: Agrees with
Doppler
Results
Agreement of Unrested and Rested Ability
Bias = –0.026
95% limit of agreement = ±0.21
Objective achieved: No rest required
Results
Test Timings
Mean time
Ability
Unrested
7.1 min
Doppler
Rested
31.5 min
Summary of
Clinical Study
 Good agreement between Doppler and Ability
 The Ability measurement takes significantly less time than
Doppler and obviates the need for a rested patient by the
simultaneous cuff inflation improving the whole patient
experience
 The Ability has the potential to be used as a screening tool for
PAD in primary care settings by increasing the patient throughput
and its simplicity allows it to be operated by a Healthcare
Support Worker.
 Allows earlier diagnosis and intervention for lifestyle changes
and risk factors
 Study provided clinical evidence that the innovative technique
worked
Design
Local market research amongst potential users was undertaken
to develop the correct concept design and its accessories.
Automatic Ankle Brachial Index
System
1.06
136
146
normal
ABI
84
138
0.61
moderate
PVR
printout
Automatic Ankle Brachial Index
System
Two chamber cuffs are connected to the Ability unit
Collaboration with the Design of
Accessories
Developing the carry bag and trolley
Evaluating the Disposable Sleeves
Disposable sleeves
 For improved infection control
 Eliminates the need to clean
cuffs
 Fits ankles and arms
PRIMARY CARE
Portability
Home visits
Hospital
Clinic
SECONDARY CARE
Community
Clinic
Advantages of Local
Collaboration
 Regular succinct brainstorming meetings for:
 planning
 problem solving
 quick resolution of technical problems
 improving usability of the product
 reviewing risk analysis
 provided clinical input at many stages of the project
 Allowed for smooth running of study and more efficient
data collection.
Future Collaboration
 Primary Care study with GP’s
 To reduce the number of referrals to secondary care
 To indentify the use of Ability as a cost effective
assessment tool
 Funding opportunities are being sought
 Masters in Research (MRes) – PVR study
 Improve the identification of PVR waveforms
 How they correlate with the Doppler waveforms
 Secondary Care study – ABI and TBI vs Duplex scan
 How well ABI and TBI PAD diagnosis compares with Duplex
scans
 Development of the large cuff design
Thank you for your Attention